Hansoh being the First in Passing the Consistency Evaluation for imatinib mesylate

Jiangsu Hansoh Pharmaceutical received the Approval Document on the Drug Supplementary Application for imatinib mesylate issued by SDA (State Drug Administration of China, formerly CFDA) on July 5, to become the first pharmaceutical enterprise in passing the consistency evaluation of this pharmaceutical product in China. Currently, the imatinib mesylate capsules under Chia Tai Tianqing is also in the process of application for generic drug consistency evaluation, besides the relevant tablets of Hansoh Pharmaceutical.

The story behind the miracle drug

Imatinib mesylate is a first-line drug for chronic myeloid leukemia (CML). The ten-year survival in CML patients has increased from previously less than 50% to about 90% thanks to this anti-cancer miracle drug. The trade name of original drug of this life-saving drug is Gleevec which was developed by Novartis, with the capsules marketed in the U.S. in May 2001 and entering the Chinese market in April 2002, and the tablets approved in China in December 2004.

The compound patent of this original drug of Novartis expired in China in 2013, and currently there are 3 Chinese pharmaceutical enterprises with generic drugs of Gleevec approved for marketing in China, separately Hansoh Pharmaceutical, Chia Tai Tianqing, and CSPC Ouyi.

Gleevec, the first small molecule targeted anti-cancer drug successfully developed in human history, took 42 years and cost billions of USD, from the discovery of the therapeutic target "Philadelphia chromosome" to the successful marketing for the cancer treatment. During the breeding of Gleevec, the humanity discovered the chromosome variation and chromosomal translocation in tumor cells for the first time, and it led to 5 members of the National Academy of Sciences and 1 winner of the U.S. National Natural Science Award. This anti-cancer miracle drug can be said to be crystallization of common wisdom of mankind.

Chinese-produced imatinib mesylate’s passing of the consistency evaluation from the perspective of the bid-winning price

The realistic film Dying to Survive starring Xu Zheng directed by Wen Muye has been hotly released recently; the topic involved in this film has rapidly ignited the WeChat Moments, and the realistic story has moved many Chinese people.

The miracle drug in the film, i.e., the original drug "Glinic" with a sky-high price, in fact alludes to Gleevec. The price of Gleevec when it entered China in 2001 was RMB 23,500/box, and a patient needed to pay more than RMB 280,000 a year for the drug and take it for life: the drug expenses could be called sky-high.

There are currently 4 manufacturers selling imatinib mesylate on the Chinese market. According to the data of the Insight database, the sales of imatinib mesylate reached RMB 1.918 billion in China in 2016, wherein, Novartis’ Gleevec accounted for 80.29% of the entire market, followed by Hansoh Pharmaceutical’s Xinwei, Chia Tai Tianqing’s Genike, and CSPC Ouyi’s Nuolining.

We’ve selected Jiangsu, Beijing and Sichuan from the regions in China for comparison of differences of bid-winning prices of original drug and Chinese-produced generic drugs in 2018, as shown in the following table:

We can see from the data in the table that the bid-winning prices of the original drug Gleevec do not vary much in the three places, with the highest price of RMB 11,620 and the lowest price of RMB 10,500, and the other three drugs have the similar situation, however, the bid-winning prices of Chinese-produced drugs significantly differ from those of the original drug; the Chinese-produced drug with the highest bid-winning price is Xinwei in the above three places, with the bid-winning price per box less than 1/9 of that of Gleevec.

Take Jiangsu Province for instance, Xinwei has been formally included in the medical insurance of Jiangsu Province since January 1, 2015, with the reimbursement ratio for urban workers and residents of 75%. The annual expenses for a patient to use Xinwei is roughly estimated to be about RMB 3,480, far lower than that of Gleevec.

If an important reason resulting in Chinese patients to fail to enjoy cost-effective, high-quality generic drugs that are similar to original drugs is the circumstances that Chinese generic drugs were of varying quality and some generic drugs had quality and efficacy far lower than those of original drugs before the conduct of the generic drug quality and efficacy consistency evaluation in China, then, the passing of consistency evaluation of Hansoh Pharmaceutical’s Imatinib Mesylate Tablets this time will mark a new beginning: passing consistency evaluation means that the generic drug is consistent with the original drug and can substitute the latter. And we hope to see the gradual growth of Chinese-made miracle drugs upon their price advantages, and that there will be no longer patients shedding tears in the real world implied in the film Dying to Survive.

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